EUCTR2017-004971-30-BE进行中（未招募）1 期
A Phase 2a Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of Bris10 M2SR (H3N2 A/Brisbane/10/2007) Vaccine Administered as a Single Intranasal Dose (Versus Placebo) in Healthy Adult Volunteers who are Subsequently Challenged with a Live, Antigenically Different Wild-type Influenza Type A Virus (A/Belgium/4217/2015 H3N2)
FluGen, Inc0 个研究点目标入组 120 人开始时间: 2018年2月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Give written informed consent to participate.
- •2. Age 18 – 55 years old, inclusive.
- •3. Judged suitable by the Principal Investigator, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations.
- •4. Negative test for pregnancy at screening visit, on Day-28 and at Day -2.
- •5. Negative test for alcohol (breath) and drugs of abuse (urine).
- •6. Negative test for influenza prior to vaccination.
- •7. Female subjects should fulfill one of the following criteria:
- •a. Post-menopausal status defined as no menses for 12 months without an alternative medical cause and/or high follicle-stimulating hormone (FSH) level (>30 mIU/mL) prior to screening.
- •b. Surgically sterile.
- •c. Willing to use oral, implantable, transdermal or injectable contraceptives, as outlined in inclusion criteria 8, from screening and until 28 days after challenge infection.
- •8. Female subjects of childbearing potential must agree to use a reliable form of contraception approved by the Investigator (e.g., oral, implantable, transdermal, or injectable contraception, combined oral, intrauterine device [IUD], or a sterile sexual partner) from screening and until 28 days after challenge infection. Non-surgically sterile male subjects who are sexually active with a female partner(s) of childbearing potential (i.e. males who have not been sterilized by vasectomy for at least 6 months prior to screening) must be willing to use condoms from screening and until 28 days after challenge infection.
- •9. Willing to adhere to the requirements of the study and willing and able to communicate with the Investigator and understand the requirements of the study.
- •10. Willing to be confined during the challenge portion of the study.
- •11. Non-smoker (including prior smokers having stopped smoking for more than 1 year at time of screening) or non-habitual smoker (non-habitual smokers are persons who smoke fewer than 4 cigarettes or other tobacco products on a weekly basis) who agrees to not use tobacco products during the challenge phase of the study.
- •12. Absent or low levels of detectable pre-existing antibodies to influenza virus H3N2 subtype, strain A/Belgium/4217/2015, as determined by a MN titer of =20 at screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any subject who is a family member of a) study site personnel, b) personnel involved in conduct or monitoring of study, or c) Sponsor.
- •2.Has a BMI at screening of less than or equal to 19.0 kg/m2 or greater than or equal to 32.0 kg/m2.
- •3.Any condition that would limit the subject’s ability to complete the study based on the opinion of the Investigator
- •4.Abnormal screening hematology or chemistry value per the FDA
- •5.Pulse rate, blood pressure, or ECG outside the reference range for this study population and considered as clinically significant by the Investigator.
- •6.Has an acute or chronic medical condition or history of a medical condition
- •7. Has been vaccinated against influenza within the last 6 months or plans to be inoculated with an influenza vaccine (other than study vaccine) until one month after completion of in-person follow up.
- •8.Had a flu-like illness, influenza treatment, or prophylactic influenza viral drug administered in the previous 6 months before screening.
- •9Positive screening test or known infection with HIV, HBV and HCV.
- •10.History of cancer within 5 years prior to screening
- •11.Presence or history of lung disease, asthma, chronic obstructive pulmonary disease, or otherwise poor lung function. Childhood asthma that resolved by age 12 years is not criteria for exclusion.
- •12.Having a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio <0.70 and FEV1 <80 % at screening. The interpretation of the spirometry result is at the investigator’s discretion. At the discretion of the investigator or designee, subjects with up to 10% deviation from these values may be included.
- •13.Any significant abnormality altering the anatomy of the nose or nasopharynx. A test swabbing by mock swab may be performed at screening at the Investigator’s discretion.
- •14.Any confirmed or suspected immunosuppressive or immunodeficient state including: asplenia, recurrent severe infections and chronic immunosuppressant medication within the last 6 months.
- •15.Use of immunosuppressive medications, such as allergy shots, immune globulin, interferon, immunomodulators, in the past 6 months or planned to be used during the course of the trial.
- •16.Use of intranasal corticosteroids within the last 7 days before screening.
- •17.Significant adulthood history of seasonal hay fever, a seasonal allergic rhinitis, perennial allergic rhinitis, chronic nasal or sinus condition such as sinusitis, at the discretion of the investigator.
- •18.Received any licensed vaccine within 1 month before screening or planned receipt during the 30 days post challenge.
- •19. Received or planned administration of another investigational vaccine or drug during the period from 90 days prior to Day 1 to 1 month after completion of in-person follow up.
- •20.History of allergy/hypersensitivity to any vaccine or virus challenge component challenge agent component or material in nasal delivery device
- •21.Experienced a life-threatening reaction(s) after a previous administration of any vaccine, or experienced an allergic reaction after a previous administration of any influenza vaccine or component.
研究者
相似试验
进行中（未招募）
不适用
未命名试验Influenza A (H1N1) infectionMedDRA version: 18.0Level: LLTClassification code 10063211Term: Influenza A virus IgGSystem Organ Class: 100000004848EUCTR2015-000574-35-BEVisterra, Inc.
已完成
2 期
A Study of JNJ-64304500 as Add-on Therapy in Participants with Active Crohn's DiseaseCrohn DiseaseJPRN-jRCT2031200406umaguchi Hirotaka70
进行中（未招募）
1 期
A phase 2a study of CR9114 in healthy adult participantsInfluenza virusCTIS2023-505020-57-00eyden Laboratories B.V.140
已完成
2 期
A Phase 2a Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects With Diabetic Kidney DiseaseJPRN-jRCT2080225044AstraZeneca KK30
进行中（未招募）
1 期
A clinical study to evaluate the safety and effectiveness of JNJ-64304500 as an add-on therapy to standard of care biologic therapy with anti-tumor necrosis factor alpha or anti-interleukin 12/23 in responder not remitter participants with active Crohn's DiseaseEUCTR2020-002701-26-ITJANSSEN CILAG INTERNATIONAL NV70